CN214807782U

CN214807782U - Central catheter capable of being inserted quickly and catheter tube

Info

Publication number: CN214807782U
Application number: CN202022408306.4U
Authority: CN
Inventors: G·H·豪厄尔
Original assignee: Bard Access Systems Inc
Current assignee: Bard Access Systems Inc
Priority date: 2019-10-27
Filing date: 2020-10-26
Publication date: 2021-11-23
Anticipated expiration: 2030-10-26
Also published as: EP4031221A1; AU2020372873A1; CA3157529A1; WO2021086793A1; CN112704803A; US20210121661A1; JP2022553285A; EP4031221A4; MX2022004856A

Abstract

A rapidly insertable central catheter ("RICC") and catheter tubing are disclosed. For example, the RICC may include: a conduit tube; a suture wing disposed on the middle portion of the catheter tube; a hub coupled to a proximal portion of the catheter tubing; and a plurality of extension legs extending from the bushing. The catheter tubing may comprise a first section in a distal portion of the catheter tubing and a second section proximal to the first section. The second section of the catheter tube may include an outer layer extruded over the inner layer such that an outer diameter of the catheter tube in the second section is greater than an outer diameter of the catheter tube in the first section. The catheter tube may have a column strength sufficient to prevent buckling of the catheter tube when inserted to the insertion site and advanced through the vasculature of the patient.

Description

Central catheter capable of being inserted quickly and catheter tube

Priority

This application claims priority to U.S. provisional application No. 62/926,559 filed on 27/10/2019, which is incorporated by reference in its entirety.

Technical Field

The present application relates to the field of medical devices, and more particularly to a rapidly insertable central catheter and catheter tubing.

Background

Central venous catheters ("CVCs") are formed of materials having a relatively low durometer, which results in a lack of column strength for the CVC. Due to the lack of column strength, CVCs are typically introduced into a patient and advanced through the patient's vasculature via the Seldinger (Seldinger) technique. The seldinger technique utilizes multiple steps and multiple medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). While the seldinger technique is effective, the multiple steps are time consuming, handling multiple medical devices is cumbersome, and both can cause trauma to the patient. Furthermore, the likelihood of touch contamination is relatively high due to the need to interchange multiple medical devices during multiple steps of the seldinger technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient and advancing the catheter through the vasculature of the patient.

Disclosed herein are rapidly insertable central catheters ("RICCs") and methods thereof that address the above-mentioned problems.

SUMMERY OF THE UTILITY MODEL

Disclosed herein is a RICC, which in some embodiments comprises: catheter tube (catheter tube); a suture wing (suture wire) disposed on the middle portion of the catheter tube; a hub (hub) coupled to a proximal portion of the catheter tubing; and a number of extension legs (extensions leg) extending from the liner equal to the number of lumens extending through the RICC. The catheter tube includes a first section in a distal portion of the catheter tube and a second section proximal to the first section. The second section of the catheter tube comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that the outer diameter of the catheter tube in the second section is larger than the outer diameter in the first section.

In some embodiments, the inner layer of the catheter tube is formed of a first polymeric material having a first hardness and the outer layer of the catheter tube is formed of a second polymeric material having a second hardness, the second hardness being less than the first hardness.

In some embodiments, the inner layer of the catheter tube is formed of a first polymeric material having a first hardness and the outer layer of the catheter tube is formed of a second polymeric material having a second hardness, the second hardness being substantially equal to the first hardness.

In some embodiments, each of the first polymeric material and the second polymeric material is a polyurethane.

In some embodiments, each of the inner and outer layers of the catheter tubing are formed from the same polymeric material.

In some embodiments, the polymeric material is a polyurethane.

In some embodiments, the catheter tube further comprises a ridge delineating (demarrate) a third section of the catheter tube proximal to the second section. The third section has an outer diameter greater than the outer diameter of both the first and second sections of the catheter tubing.

In some embodiments, the suturing wing is disposed on the bulge of the catheter tube such that an outer diameter of the catheter tube proximal to the suturing wing is greater than an outer diameter of the catheter tube distal to the suturing wing.

In some embodiments, the catheter tube between the suture wing and the hub has a reverse taper (reverse taper), wherein the outer diameter of the catheter tube increases continuously from the suture wing to the hub.

In some embodiments, the RICC is a three lumen catheter comprising a trifurcated (trifurcated) liner as the liner. The RICC also has three extension legs extending from the liner. Each of the three extension legs includes a luer connector coupled to a proximal portion of the extension leg.

In some embodiments, the RICC comprises: a first lumen extending from an opening in a proximal end of the first luer connector to an opening in a distal end of the first section of the catheter tubing; a second lumen extending from an opening in a proximal end of a second luer connector to a first eyelet (eyelet) in a distal portion of a second section of the catheter tubing; and a third lumen extending from an opening in the proximal end of the third luer connector to a second eyelet in the distal portion of the second section of the catheter tubing.

In some embodiments, the RICC is a dual lumen catheter including a bifurcated (bifurcated) liner as the liner. The RICC also has two extension legs extending from the liner. Each of the two extension legs includes a luer connector coupled to a proximal portion of the extension leg.

In some embodiments, the RICC comprises: a first lumen extending from an opening in a proximal end of the first luer connector to an opening in a distal end of the first section of the catheter tubing; and a second lumen extending from an opening in the proximal end of the second luer connector to an eyelet in the distal portion of the second section of the catheter tubing.

In some embodiments, the catheter tube has a column strength sufficient to prevent buckling of the catheter tube when inserted to the insertion site and advanced through the vasculature of the patient.

Also disclosed herein is a catheter tube, which in some embodiments includes a first section in a distal portion of the catheter tube and a second section proximal to the first section. The second section of the catheter tube comprises an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that an outer diameter of the catheter tube in the second section is larger than an outer diameter in the first section. The catheter tubing has a column strength sufficient to prevent buckling of the catheter tubing as it is inserted into the insertion site and advanced through the patient's vasculature without the use of the seldinger technique.

In some embodiments, the polymeric material is a polyurethane.

In some embodiments, the catheter tube further comprises a ridge delineating a third section of the catheter tube proximal to the second section. The third section has an outer diameter greater than the outer diameter of both the first and second sections of the catheter tubing.

In some embodiments, the catheter tube between the bump and the proximal end of the third section of the catheter tube has an inverted cone shape, wherein the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third section of the catheter tube.

In some embodiments, the catheter tubing is a triple lumen catheter tubing comprising: a first lumen extending from a first opening in the proximal end of the catheter tube to an opening in the distal end of the first section of the catheter tube; a second lumen extending from a second opening in the proximal end of the catheter tube to a first eyelet in a distal portion of the second section of the catheter tube; and a third lumen extending from a third opening in the proximal end of the catheter tube to a second aperture in the distal portion of the second section of the catheter tube.

In some embodiments, the catheter tubing is a dual lumen catheter tubing comprising: a first lumen extending from a first opening in the proximal end of the catheter tube to an opening in the distal end of the first section of the catheter tube; and a second lumen extending from a second opening in the proximal end of the catheter tube to an eyelet in the distal portion of the second section of the catheter tube.

Also disclosed herein is a method for manufacturing a layered catheter tubing, such as the aforementioned catheter tubing, which in some embodiments includes an inner layer forming step: the inner layer of the catheter tubing is formed by extruding a single lumen tubing of a first polymeric material. The method further comprises the step of inserting: one end of the single lumen tubing is inserted through the die of the extruder. The method further comprises a second layer forming step of: forming an outer layer of the catheter tube by periodically forcing a melt of a second polymeric material through a mold surrounding the single lumen tube, thereby forming a hybrid tubing (tubing) having segments of the single lumen tube interspersed with segments of the layered tubing. The method further comprises a drawing step: the hybrid layer tube was drawn through a cooling bath using a puller (puller) to cool the hybrid layer tube. The method further comprises a cutting step: cutting the hybrid layer tubing in at least a section of the single lumen tubing using a cutter to form a layered catheter tube.

In some embodiments, the method further comprises a lumen forming step: one or more additional lumens are formed relative to the lumen of the single lumen tubing by injecting air into the melt of the second polymeric material while forcing the melt of the second polymeric material through a die surrounding the single lumen tubing.

In some embodiments, the method further comprises a perforation generating step: one or more perforations are created in a section of the layered tubing to correspondingly establish one or more openings for one or more additional lumens.

In some embodiments, the method further comprises a bump forming step: an outer diameter bump is formed in a section of the layered tube by periodically slowing the rate at which the hybrid layer tube is drawn using a puller to increase the outer diameter after the bump.

In some embodiments, the method further comprises the step of forming an inverted cone: the outer diameter of the section of the clad tubing after the bump is reverse tapered by continuously slowing down the rate at which the clad tubing is drawn using a puller.

In some embodiments, the method further comprises an adhesive layer application step: a bonding layer is applied to the single lumen tubing before forcing a melt of the second polymeric material through a mold surrounding the single lumen tubing.

In some embodiments, the first polymeric material has a first durometer and the second polymeric material has a second durometer, the second durometer being less than the first durometer.

In some embodiments, the first polymeric material has a first durometer and the second polymeric material has a second durometer, the second durometer being substantially equal to the first durometer.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the drawings and following description, which describe in greater detail certain embodiments of these concepts.

Drawings

Fig. 1 illustrates an isometric view of a RICC according to some embodiments.

Fig. 2 illustrates an exploded view of a RICC according to some embodiments.

Fig. 3 illustrates a distal portion of a catheter tubing of a RICC according to some embodiments.

Fig. 4A illustrates a first transverse cross-section of a catheter tubing according to some embodiments.

Fig. 4B illustrates a second transverse cross-section of a catheter tubing according to some embodiments.

Fig. 4C illustrates a third transverse cross-section of a catheter tubing according to some embodiments.

Fig. 4D illustrates a fourth or fifth transverse cross-section of a catheter tubing according to some embodiments.

Fig. 5 illustrates a portion of a method of manufacturing a catheter tubing according to some embodiments.

Detailed Description

Before disclosing in greater detail some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It is also to be understood that features of particular embodiments disclosed herein can be readily separated from the particular embodiments, and optionally combined with or substituted for the features of any of the various other embodiments disclosed herein.

With respect to the terms used herein, it is also to be understood that these terms are for the purpose of describing some particular embodiments, and that these terms are not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or different steps in a set of features or a set of steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps need not necessarily be present in order, and particular embodiments that include such features or steps need not necessarily be limited to the three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear" are used for convenience and are not intended to imply any particular fixed position, orientation, or direction, for example. Rather, such tags are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

For example, when the catheter is used on a patient, reference to a "proximal," "proximal portion," or "proximal portion" of the catheter disclosed herein includes the portion of the catheter intended to be in proximity to the clinician. Likewise, for example, when the catheter is used on a patient, the "proximal length" of the catheter includes the length of the catheter that is intended to be proximal to the clinician. For example, when the catheter is used on a patient, the "proximal end" of the catheter includes the end of the catheter intended to be proximal to the clinician. The proximal portion, proximal end portion, or proximal length of the catheter may comprise the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the distal portion or end length of the catheter.

For example, when the catheter is used on a patient, reference to "distal", "distal portion" or "distal portion" of the catheter disclosed herein includes the portion of the catheter that is intended to be near or within the patient. Likewise, for example, when the catheter is used on a patient, the "distal length" of the catheter includes the length of the catheter that is intended to be near or within the patient. For example, when the catheter is used on a patient, the "distal end" of the catheter includes the end of the catheter that is intended to be near or within the patient. The distal portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, or distal length of the catheter is not the tip portion or end length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

As above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient and advancing the catheter through the vasculature of the patient. Disclosed herein are RICCs and methods thereof that address the above-mentioned problems.

Central catheter capable of being inserted quickly

Fig. 1 illustrates an isometric view of a RICC 100 according to some embodiments. Fig. 2 illustrates an exploded view of the RICC 100 according to some embodiments.

As shown, the RICC 100 includes a catheter tube 110, suture wings 140, a sleeve 150, and a plurality of extension legs 160 extending from the sleeve 150.

The suture wing 140 is disposed on an intermediate portion of the catheter tube 110 between the proximal and distal portions of the catheter tube 110. The suture wing 140 includes a through-hole extending longitudinally through the suture wing 140 configured for insertion of the catheter tube 110 therethrough (see, e.g., fig. 2).

The suturing wing 140 includes a pair of wings 142, and the pair of wings 142 includes a plurality of through holes 244 for suturing the suturing wing 140 to the patient. Each of the pair of wings 142 may include one through hole, two through holes, three through holes, or four through holes for suturing the suturing wings 140 to the patient.

The hub 150 is coupled to the proximal portion of the catheter tube 110, such as by inserting the proximal portion of the catheter tube 110 into an internal bore (bore) in the distal portion of the hub 150. Although not shown, the bushing 150 also includes a number of internal bores corresponding in number to the number of extension legs 160 in the proximal portion of the bushing 150. The plurality of bores in the distal portion of the bushing 150 are configured to accept insertion of the plurality of extension legs 160 into the plurality of bores.

The RICC 100 can be a single lumen catheter or a multi-lumen catheter (e.g., a dual lumen catheter, a three lumen catheter, a four lumen catheter, a five lumen catheter, or a six lumen catheter). Thus, the liner 150 is not bifurcated for a single lumen catheter or is bifurcated according to multiple lumens extending through the RICC 100. For example, the bushing 150 may be bifurcated for a dual lumen catheter or may be trifurcated for a triple lumen catheter. Depending on the manufacturing method selected, the hub 150 may be molded over a plurality of core pins to form a plurality of fluid passages extending longitudinally through the hub 150 configured to fluidly connect the plurality of catheter tubing lumens of the catheter tubing 110 to the plurality of extension leg lumens of the plurality of extension legs 160. Alternatively, the hub 150 may be molded over a plurality of sleeves extending longitudinally through the hub 150 configured to fluidly connect the plurality of catheter tube lumens of the catheter tube 110 to the plurality of extension leg lumens of the plurality of extension legs 160.

A plurality of extension legs 160 extend from the bushing 150 by way of their distal portions. The number of extension legs 160 is equal to the number of lumens extending through the RICC 100. For example: if the RICC 100 is a single lumen catheter, one extension leg extends from the hub 150. If the RICC 100 is a dual lumen catheter, two extension legs extend from the hub 150. If the RICC 100 is a three lumen catheter, three extension legs extend from the hub 150.

The RICC 100 further includes a plurality of luer connectors 170 for fluidly connecting a plurality of medical devices to the RICC 100. Each of the plurality of extension legs 160 includes a luer connector of the plurality of luer connectors 170 coupled to a proximal portion of the extension leg. In view of the foregoing, the number of luer connectors 170 is equal to the number of extension legs 160, which in turn is equal to the number of lumens extending through the RICC 100. For example: if the RICC 100 is a single lumen catheter, one extension leg extends from the hub 150 and one luer connector is coupled to one extension leg. If the RICC 100 is a dual lumen catheter, two extension legs extend from the hub 150 and two luer connectors are coupled to the two extension legs, respectively. If the RICC 100 is a three lumen catheter, three extension legs extend from the hub 150 and three luer fittings are respectively coupled to the three extension legs.

The catheter tubing 110 comprises at least a first section 212 in a distal portion of the catheter tubing 110 and a second section 214 proximal to the first section 212 of the catheter tubing 110. The conduit tube 110 may include a transition 216 between the first section 212 and the second section 214 of the conduit tube 110 according to a method of manufacturing the conduit tube 110 set forth below. Indeed, according to the manufacturing method set forth below, the second section 214 of the catheter tubing 110 comprises an outer layer 414 (see fig. 4A to 4D) of the catheter tubing 110 extruded on an inner layer 412 (see fig. 4A to 4D) of the catheter tubing 110 such that the outer diameter of the catheter tubing 110 in the second section 214 is greater than the outer diameter of the catheter tubing 110 in the first section 212, the second section starting from the transition 216 between the first section 212 and the second section 214 of the catheter tubing 110.

The inner layer 412 of the catheter tube 110 is formed of a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first hardness, while the outer layer 414 of the catheter tube 110 is formed of a second polymeric material (e.g., polyvinyl chloride, polyethylene, polyurethane, or silicone) having a second hardness that is less than, greater than, or substantially equal to the first hardness. For example, each of the inner layer 412 and the outer layer 414 of the catheter tubing 110 may be made of different polyurethanes having different hardnesses (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, etc.). In fact, polyurethane is advantageous for the catheter tubing 110 because polyurethane can be relatively rigid at room temperature, but becomes more flexible in vivo at body temperature, which reduces irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous because thrombosis may be formed less than some other polymers.

It should be understood that the first hardness and the second hardness may be on different scales (e.g., type a or type D). Thus, if the second hardness of the second polymeric material is less than the first hardness of the first polymeric material, the second hardness may not be numerically less than the first hardness. Likewise, if the second hardness of the second polymeric material is greater than the first hardness of the first polymeric material, the second hardness may not be greater in value than the first hardness. That is, the hardness of the second polymeric material may still be less than or greater than the hardness of the first polymeric material, as different scales (from 0 to 100 on each scale) are designed to characterize different materials in a group of materials having similar hardness.

Although as before, the inner and

outer layers

412, 414 of the catheter tube 110 may be formed of the same polymeric material (e.g., polyurethane) having substantially equal stiffness, provided that the column strength of the catheter tube 110 is sufficient to prevent buckling of the catheter tube 110 when inserted to an insertion site and advanced through a patient's vasculature.

The catheter tube 110 having at least the first section 212 (of the first polymeric material) and the second section 214 (having the inner layer 412 of the first polymeric material and the outer layer 414 of the second polymeric material) has a column strength sufficient to prevent buckling of the catheter tube 110 when the catheter tube 110 is inserted to an insertion site and advanced through a patient's vasculature. The column strength of the catheter tube 110 is significant because it allows for rapid insertion of the catheter tube 110 to the insertion site and advancement of the catheter tube 110 through the vasculature of the patient without using the seldinger technique.

The catheter tubing 110 may comprise a third section 218 proximal to the second section 214 of the catheter tubing 110, the third section 218 comprising a raised diameter delineated by a raised portion 217 in a middle portion of the catheter tubing 110. The third section 218 of the conduit tube 110 has an outer diameter that is greater than the outer diameter of both the first section 212 and the second section 214 of the conduit tube 110. The suture wing 140 may be disposed on the protuberance 217, as shown in fig. 1 and 2. Thus, the outer diameter of the catheter tube 110 proximal to the suture wings 140 (also referred to herein as catheter tube extension) is larger than the outer diameter of the catheter tube 110 distal to the suture wings 140. The larger outer diameter of the catheter tube 110 at the proximal third section 218 of the suture wing 140 provides a thicker, more kink-resistant catheter tube wall that can be used to bend the bushing 150 and the plurality of extension legs 160 away from the head or neck of the patient when the RICC 100 is in use. Furthermore, the diameter of any lumen present in the catheter tube 110 proximal to the suture wings 140 in the third section 218 of the catheter tube 110 may be larger than the diameter distal to the suture wings 140. This prevents a reduction in flow rate, particularly when the proximal third section 218 of the suture wing 140 of the catheter tube 110 is bent away from the head or neck of the patient.

The catheter tube 110 between the suturing wing 140 and the bushing 150 may have an inverted cone shape, wherein a larger outer diameter of the catheter tube 110 continues to increase from the suturing wing 140 to the bushing 150. In other words, the catheter tube 110 tapers from the bushing 150 to the suture wing 140, but continues to have a larger outer diameter than the catheter tube 110 distal to the suture wing 140. In association with the continuously increasing outer diameter of the catheter tube 110 from the suture wings 140 to the bushing 150, the thickness of the catheter tube wall may continuously increase, the cross-sectional area of any lumen of the catheter tube 110 may continuously increase, or a combination thereof. Thus, the catheter tube 110 between the suture wing 140 and the hub 150 may be more kink resistant and resist flow rate reduction, particularly when the catheter tube 110 proximal to the suture wing 140 is bent away from the head or neck of the patient. Although as before, the catheter tube 110 between the suture wings 140 and the bushing 150 may alternatively have a constant diameter from the suture wings 140 to the bushing 150.

Advantageously, the catheter tube 110 (e.g., the third section 218 of the catheter tube 110) or catheter tube extension between the suturing wing 140 and the hub 150 is a single catheter tube configured to reduce bacterial ingress between a dressing applied on the suturing wing 140 and the skin of the patient. Existing CVCs or peripherally inserted central catheters ("PICCs") have multiple extension legs that extend from the suture wing-hub combination common to CVCs and PICCs. The multiple legs in the CVC or PICC provide multiple pathways for microbial access under the dressing. The catheter tube 110 is a single catheter tube between at least the suture wings 140 and the hub 150, enabling the dressing to pinch more tightly around the catheter tube 110 than the multiple extension legs of existing CVCs or PICCs. For example, the dressing may easily be wrapped around the entire catheter tube 110 and pinched together under the catheter tube 110 between the catheter tube 110 and the patient. In contrast, even if the dressing is wrapped around multiple extension legs of an existing CVC or PICC as described for the catheter tubing extension, gaps are left between adjacent extension tubes for bacteria to enter. Thus, the catheter tube 110, being a single catheter tube, limits bacterial access between the dressing applied on the suturing wing 140 and the patient's skin.

The catheter tube 110 or catheter tube extension between the suture wing 140 and the hub 150 is also configured to reduce discomfort to the patient due to the proximity of the plurality of extension legs 160 to the head or neck of the patient. As described above, the third section 218 of the catheter tube 110 proximal to the suture wings 140 provides a thicker, more kink-resistant catheter tube wall; however, the third section 218 of the catheter tubing 110 is sufficiently flexible to enable the catheter tubing 110 to be completely distal to the head or neck of the patient and secured to the patient for comfort.

Fig. 3 illustrates a distal portion of a catheter tubing 110 of a RICC 100 according to some embodiments. Fig. 4A to 4D illustrate various transverse cross-sections of a catheter tubing according to some embodiments.

Also, the RICC 100 can be a single lumen catheter or a multi-lumen catheter (such as a dual lumen catheter, a three lumen catheter, a four lumen catheter, a five lumen catheter, or a six lumen catheter). The catheter tubing 110 may be a single lumen catheter or a multi-lumen catheter (such as a double lumen catheter, a three lumen catheter, a four lumen catheter, a five lumen catheter, or a six lumen catheter, respectively).

When the RICC 100 is configured as a three lumen catheter as shown in fig. 1, 2, and 4A-4D, the RICC 100 includes a first lumen, a second lumen, and a third lumen. The first lumen extends from an opening in a proximal end of a first of the plurality of luer connectors 170 to an opening in a tip or in a distal end of the first section 212 of the catheter tubing 110. The second lumen extends from an opening in a proximal end of a second luer connector of the plurality of luer connectors 170 to an eyelet 320 in a distal portion of the second section 214 of the catheter tubing 110. The third lumen extends from an opening of a proximal end of a third of the plurality of luer connectors 170 to an eyelet 322 in a distal portion of the second section 214 of the catheter tube 110 proximal of the eyelet 320. Each of the first, second, and third lumens is further described in separate paragraphs set forth below.

The first lumen of the RICC 100 includes fluidly connected lumen sections including the first catheter tubing lumen 424 extending along the entire length of the catheter tubing 110, the first fluid passageway or first cannula lumen of the hub 150, the first extension leg lumen of the first extension leg (e.g., the extension leg labeled "distal" in fig. 1 and 2) of the plurality of extension legs 160, and the first luer connector lumen of the first luer connector of the plurality of luer connectors 170.

The second lumen of the RICC 100 includes a fluidly connected lumen section including a second catheter tubing lumen 426, the second catheter tubing lumen 426 extending proximally along the remainder of the catheter tubing 110 from the aperture 320 in the distal portion of the second section 214 of the catheter tubing 110. The fluidly connected interior cavity portion of the second interior cavity of the RICC 100 further includes the second fluid passageway or second cannula interior cavity of the hub 150, the second extension leg interior cavity of the second extension leg (e.g., the extension leg labeled "middle" in fig. 1 and 2) of the plurality of extension legs 160, and the second luer connector interior cavity of the second luer connector of the plurality of luer connectors 170.

The third lumen of the RICC 100 includes fluidly connected lumen sections including a third catheter tube lumen 428, the third catheter tube lumen 428 extending proximally along the remainder of the catheter tube 110 from the aperture 322 in the distal portion of the second section 214 of the catheter tube 110. The fluidly connected interior cavity portion of the third interior cavity of the RICC 100 further includes the third fluid passage or third sleeve interior cavity of the hub 150, the third extension leg interior cavity of the third extension leg (e.g., the extension leg labeled "proximal" in fig. 1 and 2) of the plurality of extension legs 160, and the third luer connector interior cavity of the third luer connector of the plurality of luer connectors 170.

When the RICC 100 is configured as a dual lumen catheter, the RICC 100 includes a first lumen and a second lumen. Like the RICC 100, when configured as a three lumen catheter, the first lumen extends from an opening in the proximal end of a first of the plurality of luer connectors 170 to an opening in the tip or distal end of the first section 212 of the catheter tubing 110. The second lumen extends from an opening in a proximal end of a second luer connector of the plurality of luer connectors 170 to an eyelet 320 in a distal portion of the second section 214 of the catheter tubing 110. Because the first and second lumens of the RICC 100 configured as a dual lumen catheter are similar to the first and second lumens of the RICC 100 configured as a three lumen catheter, additional details regarding each of the first and second lumens of the RICC 100 configured as a dual lumen catheter can be discerned from the description above regarding the first and second lumens of the RICC 100 configured as a three lumen catheter.

When the RICC 100 is configured as a single lumen catheter, the RICC 100 includes a single lumen, which for consistency with the description above is also referred to herein as the first lumen. Like the RICC 100, when configured as a three lumen catheter, the first lumen extends from an opening in the proximal end of a first of the plurality of luer connectors 170 to an opening in the tip or distal end of the first section 212 of the catheter tubing 110. Because the first lumen of the RICC 100 configured as a single lumen catheter is similar to the first lumen of the RICC 100 configured as a three lumen catheter, additional details regarding the first lumen of the RICC 100 configured as a single lumen catheter can be discerned from the description above regarding the first lumen of the RICC 100 configured as a three lumen catheter.

Method

A method for manufacturing a RICC 100 includes one or more steps set forth below for manufacturing conduit tubing 110, one or more extrusion steps for extruding one or more extrudable components other than conduit tubing 110, such as a plurality of extension legs 160, one or more molding steps for molding one or more moldable components, and one or more assembly steps for assembling the RICC 100 or any portion thereof by coupling together the extrudable components and moldable components comprising conduit tubing 110.

The one or more extrusion steps can include extruding any one or more of the plurality of feet 160 according to the description above for one or more feet.

The one or more molding steps may include molding any one or more moldable components selected from the suture wings 140 and bushings 150 described above with respect to the one or more moldable components. The one or more molding steps may further include molding any one or more of the plurality of luer connectors 170 described above with respect to the one or more luer connectors.

With an understanding that the distal portion of the catheter tube 110 is inserted into the proximal portion of the suture wings 140, one or more assembly steps to assemble the RICC 100, or any portion thereof, can include assembling the RICC 100 as shown in fig. 2.

Fig. 5 illustrates a portion of a method of manufacturing a catheter tubing 110 according to some embodiments.

The method for manufacturing a layered catheter, such as catheter tubing 110, includes an inner layer forming step: the inner layer 412 of the catheter tube 110 is formed by extruding a single lumen tubing 512 of a first polymeric material.

The method further comprises the step of inserting: one end of the single lumen tubing 512 is inserted through a die 592 of an extruder 590.

The method further comprises a second layer forming step of: the outer layer 414 of the catheter tube 110 is formed by periodically forcing a melt 594 of a second polymer material through a die 592 around the single lumen tubing 512, forming a hybrid layer tubing having segments of the single lumen tubing 512 regularly interspersed with segments of the layered tubing 514.

The method may further comprise an adhesive layer applying step of: in the second layer forming step, an adhesive layer is applied over the single lumen tubing 512 before a melt 594 of a second polymeric material is forced through a die 592 around the single lumen tubing 512.

The method further comprises a lumen forming step: one or more additional lumens (e.g., the second catheter tube lumen 426, the third catheter tube lumen 428, etc.) are formed for the lumen of the single lumen tubing 512 by injecting air into the melt 594 of the second polymeric material while forcing the melt 594 of the second polymeric material through the mold 592 around the single lumen tubing 512.

The method further comprises the step of perforation generation: one or more perforations (e.g.,

perforations

320, 322, etc.) are created in a section of the layered tubing 514 to correspondingly establish one or more openings for one or more additional lumens.

The method may further include a ridge forming step of: an outer diameter bump (e.g., bump 217 in the middle portion of catheter tube 110) is formed in a section of the layered tube 514 by periodically slowing the rate at which the hybrid layer tube is drawn using a puller to increase the outer diameter behind the bump.

The method may further comprise the step of forming an inverted cone: the outside diameter of the post-bulging section of the layered tubing 514 is inverted tapered by continuously slowing the rate at which the hybrid layer tubing is drawn using a puller.

The method may further comprise the drawing step: the hybrid layer tube is drawn through a cooling bath using a puller to cool the hybrid layer tube.

The method further comprises a cutting step: the hybrid layer tubing is cut using a cutter at least in a section of the single lumen tubing 512 to form a layered catheter tube.

The method of using the RICC 100 includes the steps of: using a needle disposed within the lumen of the RICC 100, an insertion site is created to access the vasculature of a patient. The insertion site may be at a subclavian vein (such as the right subclavian vein or the left subclavian vein), an internal jugular vein (such as the right internal jugular vein or the left internal jugular vein), or a femoral vein.

The method further comprises the step of inserting: the distal portion of the catheter tube 110 is inserted to the insertion site.

The method further comprises the extraction step of: after the insertion site is formed and at least some of the first section 212 of the catheter tubing 110 is inserted to the insertion site, the needle is withdrawn from the lumen of the RICC 100.

The method further comprises the advancing step of: the catheter tube 110 is advanced through the vasculature of a patient without having to use the seldinger technique. For example, if the insertion site is at the right subclavian vein or at the right internal jugular vein, the advancing step may further comprise inserting the catheter tube 110 further into the insertion site such that the catheter tube 110, or at least a distal portion thereof, is advanced through the right subclavian vein or the right internal jugular vein, the right brachiocephalic cerebral vein, and into the superior vena cava. Other insertion sites, such as those at the left subclavian vein or the left internal jugular vein, require advancing the distal portion of the catheter tube 110 through the corresponding vasculature. Since the catheter tube 110 has sufficient column strength to prevent buckling of the catheter tube 110 when inserted to the insertion site and advanced through the vasculature of a patient, the use of the seldinger technique is not required.

Although certain specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications will be apparent to those skilled in the art and are intended to be included in the broader aspects. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A rapidly insertable central catheter, comprising:

a catheter tubing, the catheter tubing comprising:

a first section in a distal portion of the catheter tubing; and

a second section proximal to the first section, the second section comprising an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that an outer diameter of the catheter tube in the second section is greater than an outer diameter in the first section; a suture wing disposed on a middle portion of the catheter tube;

a hub coupled to a proximal portion of the catheter tubing; and

a plurality of extension legs extending from the hub, the number of the plurality of extension legs being equal to the number of lumens extending through the central quick-insertable catheter.

2. The rapidly insertable central catheter of claim 1, wherein the inner layer of the catheter tube is formed of a first polymeric material having a first hardness and the outer layer of the catheter tube is formed of a second polymeric material having a second hardness, the second hardness being less than the first hardness.

3. The rapidly insertable central catheter of claim 1, wherein the inner layer of the catheter tube is formed of a first polymeric material having a first hardness and the outer layer of the catheter tube is formed of a second polymeric material having a second hardness that is substantially equal to the first hardness.

4. The rapidly insertable central catheter of claim 2 or 3, wherein each of the first polymeric material and the second polymeric material is polyurethane.

5. The rapidly insertable central catheter of claim 1, wherein each of the inner and outer layers of the catheter tubing are formed of the same polymeric material.

6. The rapidly insertable central catheter of claim 5, wherein the polymeric material is polyurethane.

7. The rapidly insertable central catheter of claim 1, wherein the catheter tube further comprises a ridge delineating a third section of the catheter tube proximal to the second section, the third section having an outer diameter greater than the outer diameter of both the first and second sections of the catheter tube.

8. The rapidly insertable central catheter of claim 7, wherein the suture wing is disposed on the bump of the catheter tube such that an outer diameter of the catheter tube proximal to the suture wing is greater than an outer diameter of the catheter tube distal to the suture wing.

9. The rapidly insertable central catheter of claim 1, wherein the catheter tube between the suture wing and the hub has an inverted cone shape, wherein an outer diameter of the catheter tube continuously increases from the suture wing to the hub.

10. The rapidly insertable central catheter of claim 1, wherein the rapidly insertable central catheter is a three lumen catheter comprising a three-pronged hub as a hub, the three-pronged hub having three extension legs extending therefrom, each of the three extension legs comprising a luer connector coupled to a proximal portion of the extension leg.

11. The rapidly insertable central catheter of claim 10, wherein the rapidly insertable central catheter comprises: a first lumen extending from an opening in a proximal end of a first luer connector to an opening in a distal end of the first section of the catheter tubing; a second lumen extending from an opening in a proximal end of a second luer connector to a first eyelet in a distal portion of the second section of the catheter tubing; and a third lumen extending from an opening in a proximal end of a third luer connector to a second eyelet in the distal portion of the second section of the catheter tube.

12. The quick-insertable central catheter of claim 1, wherein the quick-insertable central catheter is a dual-lumen catheter comprising a bifurcated hub as a hub, the bifurcated hub having two extension legs extending therefrom, each of the two extension legs comprising a luer connector coupled to proximal portions of the extension legs.

13. The rapidly insertable central catheter of claim 12, wherein the rapidly insertable central catheter comprises: a first lumen extending from an opening in a proximal end of a first luer connector to an opening in a distal end of the first section of the catheter tubing; and a second lumen extending from an opening in a proximal end of a second luer connector to an eyelet in a distal portion of the second section of the catheter tubing.

14. The rapidly insertable central catheter of claim 1, wherein the catheter tube has a column strength sufficient to prevent buckling of the catheter tube when inserted to an insertion site and advanced through a patient's vasculature.

15. A catheter tube, comprising:

a first section in a distal portion of the catheter tubing; and

a second section proximal to the first section, the second section comprising an outer layer of the catheter tube extruded over an inner layer of the catheter tube such that an outer diameter of the catheter tube in the second section is greater than an outer diameter in the first section, the catheter tube having a column strength sufficient to prevent buckling of the catheter tube when inserted to an insertion site and advanced through a patient vessel without using the seldinger technique.

16. The catheter tubing of claim 15, wherein the inner layer of the catheter tubing is formed of a first polymeric material having a first hardness and the outer layer of the catheter tubing is formed of a second polymeric material having a second hardness, the second hardness being less than the first hardness.

17. The catheter tubing of claim 15, wherein the inner layer of the catheter tubing is formed of a first polymeric material having a first hardness and the outer layer of the catheter tubing is formed of a second polymeric material having a second hardness that is substantially equal to the first hardness.

18. The catheter tubing of claim 16 or 17, wherein each of the first and second polymeric materials is polyurethane.

19. The catheter tubing of claim 15, wherein each of the inner and outer layers of the catheter tubing are formed of the same polymeric material.

20. The catheter tubing of claim 19, wherein the polymer material is polyurethane.

21. The catheter tubing of claim 15, wherein the catheter tubing further comprises a bump circumscribing a third section of the catheter tubing proximal to the second section, the third section having an outer diameter greater than an outer diameter of both the first and second sections of the catheter tubing.

22. The catheter tube of claim 21, wherein a catheter tube between the bump and a proximal end of the third section of the catheter tube has an inverted cone shape, wherein an outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third section of the catheter tube.

23. The catheter tubing of claim 15, wherein the catheter tubing is a triple lumen catheter tubing comprising: a first lumen extending from a first opening in a proximal end of the catheter tube to an opening in a distal end of the first section of the catheter tube; a second lumen extending from a second opening in the proximal end of the catheter tube to a first eyelet in a distal portion of the second section of the catheter tube; and a third lumen extending from a third opening in the proximal end of the catheter tube to a second aperture in the distal portion of the second section of the catheter tube.

24. The catheter tubing of claim 15, wherein the catheter tubing is a dual lumen catheter tubing comprising: a first lumen extending from a first opening in a proximal end of the catheter tube to an opening in a distal end of the first section of the catheter tube; and a second lumen extending from a second opening in the proximal end of the catheter tube to an eyelet in a distal portion of the second section of the catheter tube.